a clinical trial designed to evaluate the safety and exploratory efficacy of 1.0 mg luminate® (alg-1001) as a treatment for non-exudative macular degeneration

Conditions: Dry Age-related Macular Degeneration

Summary: to evaluate the safety and exploratory efficacy of 1.0mg of luminate® in patients with intermediate non-exudative macular degeneration

approximately 40 eligible subjects who have been diagnosed with intermediate non-exudative amd, that require treatment will be enrolled and randomized (1.7:1) to one of 2 treatment groups: treatment group 1: 25 non-exudative amd subjects with bcva of 20/40 - 20/200 will be injected intravitreally with 1.0mg of luminate® treatment group 2: 15 non-exudative amd subjects with bcva of 20/40 - 20/200 will be treated with a sham injection at the 16-week visit, the study will be unmasked to the sponsor and injecting investigator (observing investigators will remain masked). subjects in the treatment group will receive a 2nd dose of luminate®. subjects in the control group will be offered the opportunity to crossover to treatment with a single dose of luminate®.

Eligibility criteria:
inclusion criteria: * male or female patients, 50 to 85 years of age at screening visit * subject has signed the informed consent form * subjects with non-exudative amd having etdrs bcva between 33 and 72 letters read (equivalent to 20/40 - 20/200 on snellen chart) with the level of vision caused by the non-exudative amd and no other factor/s * subjects with symptomatic decrease in visual acuity in the last 12 months * subjects with combination of areas of rpe disturbances (hyper or hypopigmentation) and/or \> 1 large druse(n) (\>125 microns) and/or multiple intermediate drusen (62-124 microns) in the macula as confirmed by the central reading center * subjects with evidence of reasonably well-preserved areas of rpe by clinical examination and well-defined rpe and outer segment ellipsoid line by oct examination in the central 1 mm of the macula as confirmed by the central reading center. more specifically, reasonable reasonably well- preserved central 1 mm of the macula means: * the rpe and outer retinal layers throughout the central 1 mm are intact * no signs of nvamd such as intraretinal or sub retinal fluid, or sub retinal hyper-reflective material * no serous pigment epithelium detachments \>100 microns in height exclusion criteria: * females who are pregnant, nursing, planning a pregnancy during the study or who are of childbearing potential not using a reliable method of contraception and/or not willing to maintain a reliable method of contraception during their participation in the study. women of childbearing potential with a positive urine pregnancy test administered at baseline are not eligible to receive study drug. * participation in an investigational drug or device study within 90 days of screening * subjects with active exudative amd in the fellow eye * subjects who had anti-vegf ivt in either eye in the past 90 days * subjects with pigment epithelium detachments * subjects with active exudative amd * subjects with any prior retina surgery * subjects with pathology that could prevent observation and follow-up of macular structures and measurement of bcva (i.e. advanced primary open angle glaucoma, any stage of normal tension glaucoma and corneal opacification) * subjects that are likely to require cataract surgery in the opinion of the investigator within the study protocol period